The principalgoal of this project is to assess the economic and quality of life (EQOL) consequences of the three treatment strategies being tested in the Surgical Treatment for Ischemic Heart Failure Trial (STICH). STICH is a prospective, randomized, multicenter trial of three treatment strategies for the management of patients with clinical heart failure (HF) and left ventricular (LV) dysfunction who have coronary artery disease (CAD) amenable to revascularization (coronary artery bypass surgery [CABG]). STICH will enroll 2800 patients and address two primary hypotheses: 1) Coronary revascularization hypothesis: CABG plus intensive medical therapy improves survival compared with intensive medical therapy alone; 2) LV reconstruction hypothesis: In patients with regional LV dysfunction, surgical ventricular restoration (SVR) plus CABG improves survival free of subsequent hospitalization compared with CABG alone. All patients will receive state-of-the-art medical management (MED) for CAD and HF. There are six EQOL Specific Aims for the CABG versus Medicine comparison and six EQOL Specific Aims for the CABG Plus SVR versus CABG Alone comparison. All of these aims assume that the clinical hypotheses have been proven.
These aims will be to compare total medical costs for the two treatment arms (CABG versus MED, CABG plus SVR versus CABG) by intention-to-treat; to identify factors in addition to treatment assignment that are associated with variations in medical cost outcomes; to compare health-related quality of life for the two treatment arms by intention-to-treat; to identify factors in addition to treatment assignment that are associated with variations in quality of life outcomes; to estimate the incremental cost effectiveness of the investigational arm relative to the control arm assessed as cost per life year added and cost per quality-adjusted life year added; and to identify factors in addition to treatment assignment that are associated with variations in the cost effectiveness of the investigational arm. If efficacy is demonstrated for the primary study endpoints, then the economic and quality of life data collected as part of this proposal will clearly be pivotal in determininghow the results of this study are viewed and whether the trial findings receive widespread implementation. We will use state of the art methods for measuring cost and quality of life and for estimating cost effectiveness.
